Balloon Prophylaxis of Aneurysmal Vasospasm

Completed · Phase 2

Conditions studied: Aneurysm, Vasospasm

In brief

The purpose of this study is to determine if early transluminal ballooning of the major cerebral arteries prevents severe vasospasm and improves neurological outcome in patients with Fisher Grade III aneurysmal subarachnoid hemorrhage.

Key facts

Study ID

NCT00282893

Run by

University of California, Davis

People needed

170

Starts

2000-10-01

Expected to finish

2006-12-01

Last updated by the study team

2017-02-15

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fisher grade III hemorrhage
• Documented ruptured cerebral aneurysm via angiography, CT angiogram or any other acceptable neuroradiologic means
• Ruptured aneurysm(s) secured
• Ballooning available < 96 hours post SAH

You may not qualify if…

• Vasospasm prior to randomization
• Interventionalist unavailable
• Patient outside the 96 hour window for ballooning
• Enrolled in competing trial
• Unsecured aneurysms (symptomatic or asymptomatic) that are in the location where the ballooning procedure would occur
• Medical conditions known that would effect mortality / morbidity
• Severe Cerebrovascular atherosclerosis
• > 16 years old.

Where it is running

• Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery — Sacramento, California, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Washington - Harborview Medical Center — Seattle, Washington, United States
• University of Toronto — Toronto, Ontario, Canada
• University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100 — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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